NCT06071052CompletedPhase 2
TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens
Single-center Clinical Study of Drug-Eluting Beads-Transarterial Chemoembolization and Hepatic Artery Infusion Chemotherapy Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Who Fail Standard Treatment Regimens
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
Liver metastasis is the main reason that affects the survival rates of patients with colorectal cancer (CRLM), and is also the main cause of death of those patients. Especially after the failure of first-line or second-line system treatment, the prognosis of those patients is extremely poor, with the median OS of only 3.5 months. Even in combination with molecular targeted drugs such as cetuximab or bevacizumab, the median tumor-free survival period is only 4.8-6.8 months, and OS is only 11-15 months. When they have disease progression, treatment is currently a difficult clinical problem. Regofinib is a new targeted drug for the third-line treatment of advanced colorectal cancer in recent years. However, in the prospective multicenter clinical study, compared with the placebo group, the extended OS is only 1.4 months, which is not so satisfactory. How to improve the survival of these advanced patients with drug resistance is an important clinical problem to be solved urgently. Minimally invasive local treatment may be a promising way to solve this problem. Transcatheter arterial chemoembolization (TACE) and hepatic artery infusion chemotherapy (HAIC) are currently the most widely used methods in clinical practice. In theory, TACE combined with HAIC can control small metastasis and embolic residual lesions. The combination of TACE and HAIC can improve the curative effect. Whether the combination of TACE, HAIC and Regofinib can be expected to achieve the effect of 1+1+1\>3 in CRLM patients who have failed the previous second-line chemotherapy remains unknown. Therefore, the purpose of this study is to explore the safety and clinical efficacy of irinotecan-loaded drug-eluting beads-TACE (DEBIRI-TACE) combined with HAIC and Regofinib in the treatment of patients with CRLM who failed standard treatment regimens.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 15 Sept 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT06071052
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 21
- From 1 Dec 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with obvious artero / venous fistula and cancer plugs in the main portal vein;
- Patients who had suffered from or were currently developing other malignant tumors (except for the cured basal or squamous cell skin carcinoma or cervical carcinoma in situ);
- Patients with a history of major disease with heart, kidney, bone marrow, or lung, and central nervous system involvement;
- Patients requiring antibiotic treatment due to recent infections;
Lab values
- Patients whose white blood cells were less than 3,000 cell / mm3, or platelet count less than 50,000 / mm3;
- Patients subject to renal insufficiency (creatinine\> 2 mg/L);
- Patients whose AST and / or ALT was / were more than 5 times the upper limit of normal;
- Patients with poor coagulation function, an INR larger than 1.5, or currently subject to anticoagulant therapy or known hemorrhagic disease;
Other
- Patients with distant metastases except the liver;
- Patients subject to the treatment of TACE, ablation or iodine particles within one year;
- Patients subject to comorbidities or social environment that could prevent them from following the study plan or even endanger their safety.
Who the study is looking for
- Patients aged 18-75 years old, gender unlimited;
- Patients with liver metastasis of colorectal cancer by pathological histology or clinical diagnosis (refer to the Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastasis of Colorectal Cancer, 2016 Edition), those who were mainly exposed to liver metastasis with large tumor load and suffered from no clear extrahepatic metastasis;
- Patients with a liver area tumor no more than 5 tumor nodules, and a nodule size no more than10cm;
- Patients subject to the failure of previous chemotherapy regimen containing irinotecan or oxaliplatin after at least six cycles of systemic chemotherapy; they cannot undergo surgery or refuse surgery;
- Patients with liver tumor who did not receive interventional treatment (TACE, ablation, iodine particle treatment, etc.) within one year;
- Patients with an expected survival period longer than 3 months;
- Patients with favorable liver function (7 points for Child-Pugh A or B);
- Patients with a physical fitness ECOG no more than one point;
- Patients who understood and signed the Informed Consent Form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.